dc.contributor.author
Trendelenburg, Valérie
dc.contributor.author
Dölle-Bierke, Sabine
dc.contributor.author
Unterleider, Nathalie
dc.contributor.author
Alexiou, Aikaterina
dc.contributor.author
Kalb, Birgit
dc.contributor.author
Meixner, Lara
dc.contributor.author
Heller, Stephanie
dc.contributor.author
Lau, Susanne
dc.contributor.author
Lee, Young- Ae
dc.contributor.author
Fauchère, Florent
dc.contributor.author
Braun, Julian
dc.contributor.author
Babina, Magda
dc.contributor.author
Altrichter, Sabine
dc.contributor.author
Birkner, Till
dc.contributor.author
Roll, Stephanie
dc.contributor.author
Dobbertin-Welsch, Josefine
dc.contributor.author
Worm, Margitta
dc.contributor.author
Beyer, Kirsten
dc.date.accessioned
2024-03-21T14:02:40Z
dc.date.available
2024-03-21T14:02:40Z
dc.identifier.uri
https://refubium.fu-berlin.de/handle/fub188/42974
dc.identifier.uri
http://dx.doi.org/10.17169/refubium-42688
dc.description.abstract
Background: Peanuts (PN) and tree nuts (TN) are among the most frequent elicitors of food allergy and can lead to life-threatening reactions. The current advice for allergic patients is to strictly avoid the offending food independently of their individual threshold level, whereas sensitized patients without allergic symptoms should frequently consume the food to avoid (re-)development of food allergy. The aim of this trial is to investigate (I) whether the consumption of low allergen amounts below the individual threshold may support natural tolerance development and (II) to what extent regular allergen consumption in sensitized but tolerant subjects prevents the (re-)development of PN or TN allergy.
Methods: The TINA trial consisting of (part I) a randomized, controlled, open, parallel group, single-center, superiority trial (RCT), and (part II) a prospective observational exploratory cohort study. Children and adults (age 1-67 years) with suspected or known primary PN and/or TN allergy will undergo an oral food challenge (OFC) to determine their clinical reactivity and individual threshold. In the RCT, 120 PN or TN allergic patients who tolerate >= 100 mg of food protein will be randomized (1:1 ratio) to consumption of products with low amounts of PN or TN on a regular basis or strict avoidance for 1 year. The consumption group will start with 1/100 of their individual threshold, increasing the protein amount to 1/50 and 1/10 after 4 and 8 months, respectively. The primary endpoint is the clinical tolerance to PN or TN after 1 year assessed by OFC. In the cohort study, 120 subjects sensitized to PN and/or TN but tolerant are advised to regularly consume the food and observed for 1 year. The primary endpoint is the maintenance of clinical tolerance to PN and/or TN after 1 year assessed by challenging with the former tolerated cumulative dose.
Discussion: This clinical trial will help to determine the impact of allergen consumption versus avoidance on natural tolerance development and whether the current dietary advice for PN or TN allergic patients with higher threshold levels is still valid.
en
dc.rights.uri
https://creativecommons.org/licenses/by/4.0/
dc.subject
Randomized controlled trial
en
dc.subject
Peanut allergy
en
dc.subject
Tree nut allergy
en
dc.subject
Elimination diet
en
dc.subject
Higher threshold
en
dc.subject
Oral tolerance
en
dc.subject
Persistent food allergy
en
dc.subject.ddc
600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit
dc.title
Tolerance induction through non-avoidance to prevent persistent food allergy (TINA) in children and adults with peanut or tree nut allergy: rationale, study design and methods of a randomized controlled trial and observational cohort study
dc.type
Wissenschaftlicher Artikel
dcterms.bibliographicCitation.articlenumber
236
dcterms.bibliographicCitation.doi
10.1186/s13063-022-06149-4
dcterms.bibliographicCitation.journaltitle
Trials
dcterms.bibliographicCitation.number
1
dcterms.bibliographicCitation.originalpublishername
Springer Nature
dcterms.bibliographicCitation.volume
23
refubium.affiliation
Charité - Universitätsmedizin Berlin
refubium.funding
Springer Nature DEAL
refubium.resourceType.isindependentpub
no
dcterms.accessRights.openaire
open access
dcterms.bibliographicCitation.pmid
35346330
dcterms.isPartOf.eissn
1745-6215